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Posts Tagged National Cancer Institute

“Obama Promises $156 Million to Alzheimer’s…But where will the money come from?” That’s easy: the NCCAM!

The quoted language above is part of the headline of this story in today’s The Scientist:

Citing the rising tide of Americans with Alzheimer’s—projections suggest 10 million people will be afflicted by 2050—the Obama administration and top National Institutes of Health officials are taking action. On February 7, they announced that they will add an additional $80 million to the 2013 NIH budget for the Alzheimer’s research program.

The problem is that there ain’t no such thing as a free lunch:

However, Richard Hodes, director of the NIH’s National Institute on Aging, told Nature that the 2013 dollars still have to be approved by Congress in the next budget and, if not, existing programs may need to be cut. And this year’s $50 million is likely to bump other projects, perhaps at NIH’s National Human Genome Research Institute. “If there’s a finite budget anywhere, once there’s more of something, there is less of something else,” he said.

Often such budget compromises are difficult, because there is no ready way to choose between two or more competing recipients of taxpayers’ money, each of which might be comparably worthy. Thus it is with a great sense of relief that in this case, we in the biomedical community can assure President Obama that no such dilemma exists. This is one of those occasional decisions that requires no hair-pulling whatsoever. The obvious solution is to defund the National Center for Complementary and Alternative Medicine (NCCAM), which, at about $130 million/yr, would solve the problem of funding Alzheimer’s research and take the heat off other worthy programs such as those mentioned by Richard Hodes.

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NIH Director Francis Collins doesn’t understand the problem with CAM

As the sole cancer surgeon among our stable of Science-Based Medicine (SBM) bloggers, I’m probably the most irritated at the infiltration of pseudoscience into academia (or, as we sometimes like to call it, quackademic medicine) in the realm of cancer. Part of the reason, of course, is that cancer is so common and that the consequences of adding pseudoscience to cancer therapy are among the most devastating. Witness, for instance, the use of Gonzalez therapy to treat pancreatic cancer, a form of quackery that harms patients and resulted in incredibly unethical and disastrous clinical trial of Gonzalez quackery versus chemotherapy whose results were entirely predictable, given the lack of prior plausibility of the treatment: Gonzalez protocol patients did worse, with no evidence that the therapy impacted the natural history of the disease and the Gonzalez patients scoring lower on quality of life measures. Or look at what happens when patients with breast cancer choose quackery over science-based therapy.

I realize that “complementary and alternative medicine” (CAM) or, what quackademics like to call it now, “integrative medicine” (IM) is meant to refer to “integrating” alternative therapies into SBM or “complementing” SBM with a touch of the ol’ woo, but I could never manage to understand how “integrating” quackery with SBM would do anything but weaken the scientific foundation of medicine. Moreover, weakening those foundations would have more consequences than just “humanizing” medicine; weaker scientific standards would allow not just ancient quackery like traditional Chinese medicine (TCM) into academia, but it would also provide an opening for drug and device companies to promote their wares under less rigorous requirements for evidence. There’s also perhaps a touch of personal embarrassment involved. After all, oncology and cancer surgery tend to be specialties that are the most steeped in science. If I had to rank specialties for how science-based they are, I’d certainly put oncology near the top, which is why I tend to come down so hard on “integrative oncology” and, even worse, “naturopathic oncology.”

Consequently, I was doubly disturbed several months ago when I learned that the director of the National Institutes of Health, Francis Collins, had agreed to be the keynote speaker at the Eight International Society for Integrative Oncology Conference in Cleveland, OH. I say “doubly” disturbed because it disturbed me that Francis Collins would agree to speak at such a function and, perhaps even more, because the host institution was Case Western Reserve University, the institution where I both completed my surgery residency and my PhD in Physiology and Biophysics. Sadly, it now appears that my old stomping grounds at University Hospitals has been thoroughly infiltrated with quackademic medicine, as evidenced by this clinical trial of reiki for psoriasis that’s making the rounds of news services and the offering of acupuncture, reiki, and even reflexology at various UH facilities through the University Hospitals Connor Integrative Medicine Network. Let me tell you, there was none of this pseudoscience going on when I finished my residency there in 1996. Seeing it there now provokes a reaction in me not unlike Sylvester Junior’s reaction when his father Sylvester embarrasses him, particularly when I noted that the director of the CWRU Comprehensive Cancer Center, Dr. Stanton L. Gerson, was to give one of the keynote talks, entitled, “The Future of Integrative Oncology.” (Hint for those of you not familiar with classic Looney Tunes cartoons: A paper bag is involved.) I guess that by expressing my extreme disappointment and embarrassment that the institution where I learned to become a surgeon has during the last 15 years gone woo, I’ve probably just killed any opportunity I might have to work at the Case Comprehensive Cancer Center ever again. Oh, well, add it to the list, along with Beth Israel and my alma mater the University of Michigan.)

Back when I first learned about it, I thought about blogging the meeting, but without much concrete to go on, given the copious other SBM-related topics to blog about, all I could do was to write a critical open letter to Dr. Collins about his decision to accept the offer to be the keynote speaker at the Society for Integrative Oncology (SIO). Then yesterday I saw popping up in my e-mail a notice from the American Society of Clinical Oncology (ASCO), along with a link to a story in its publication The ASCO Post entitled NIH Director Calls for Rigorous Evaluation of Integrative Medicine to Provide Evidence of Efficacy.

Et tu, Dr. Collins?
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Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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Dr. Stanislaw Burzynski’s “personalized gene-targeted cancer therapy”: Can he do what he claims for cancer?

Last week, I wrote a magnum opus of a movie review of a movie about a physician and “researcher” named Stanislaw Burzynski, MD, PhD, founder of the Burzynski Clinic and Burzynski Research Institute in Houston. I refer you to my original post for details, but in brief Dr. Burzynski claimed in the 1970s to have made a major breakthrough in cancer therapy through his discovery of anticancer substances in the urine that he dubbed “antineoplastons,” which turned out to be mainly modified amino acids and peptides. Since the late 1970s, when he founded his clinic, Dr. Burzynski has been using antineoplastons to treat cancer. Over the last 25 years or so, he has opened a large number of phase I and phase II clinical trials with little or nothing to show for it in terms of convincing evidence of efficacy. Worse, as has been noted in a number of places, high doses of antineoplastons as sodium salts are required, doses so high that severe hypernatremia is a concern.

Although antineoplastons are the dubious cancer therapy upon which Dr. Burzynski built his fame, they aren’t the only thing he does. Despite the promotion of the Burzynski Clinic as using “nontoxic” therapies that “aren’t chemotherapy” by “natural medicine” cranks such as Joe Mercola and Mike Adams, Dr. Burzynski’s dirty little secrets, at least as far as the “alternative medicine” crowd goes, are that (1) despite all of the attempts of Dr. Burzynski and supporters to portray them otherwise antineoplastons are chemotherapy and (2) Dr. Burzynski uses a lot of conventional chemotherapy. In fact, from my perspective, it appears to me as though over the last few years Dr. Burzynski has pivoted. No longer are antineoplastons the center of attention at his clinic. Rather, these days, he appears to be selling something that he calls “personalized gene-targeted cancer therapy.” In fact, it’s right there in the first bullet point on his clinic’s webpage, underlined, even! Antineoplastons aren’t even listed until the third bullet point.

But what is “personalized gene-targeted cancer therapy,” according to Dr. Burzynski? Here is how it is described:
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Posted in: Basic Science, Cancer, Clinical Trials, Pharmaceuticals

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Stanislaw Burzynski: Bad medicine, a bad movie, and bad P.R.

And the Lord spake, saying, “First shalt thou take out the Holy Pin. Then shalt thou count to three, no more, no less. Three shall be the number thou shalt count, and the number of the counting shall be three. Four shalt thou not count, neither count thou two, excepting that thou then proceed to three. Five is right out. Once the number three, being the third number, be reached, then lobbest thou thy Holy Hand Grenade of Antioch towards thy foe, who, being naughty in my sight, shall snuff it.

Cleric from Monty Python and the Holy Grail

I’ve always wondered about the power of the number three. When it comes to quackery propaganda movies, certainly three seems to be the magic number. For example, The Greater Good, an anti-vaccine propaganda film, features three anecdotes, three children allegedly suffering from vaccine injury, and it interspersed its interviews with experts, both real (such as Dr. Paul Offit) and phony (such as Barbara Loe Fisher) with vignettes from these children’s stories interspersed between them in a highly biased manner. I have to wonder whether these cliches are taught in film school, given that they seem to be so common. Such were the thoughts running through my brain as I watched the latest medical propaganda film by writer/producer Eric Merola that’s floating around the blogosphere and the film circuit, Burzynski The Movie: Cancer Is Serious Business. In this movie, there are three testimonials, and, if anything, they are far more manipulative than even the testimonials featured in The Greater Good, because each of them are of the type that portrays doctors as sending a patient home to die; that is, until a “brave maverick doctor,” one Stanislaw R. Burzynski, MD, PhD, comes to the rescue with his unconventional and unproven therapy. The only difference is that this film counts testimonials up to the number three in the beginning as “proof” that Burzynski can cure cancer before lobbing the Holy Hand Grenade of Burzynski towards its foes in the hopes that, being naughty in the filmmaker’s sight, the FDA and Texas Medical Board will snuff it. Or, as a caption says right at very the beginning of the movie:

This is the story of a medical doctor and PhD biochemist who has discovered the genetic mechanism that can cure most human cancers. The opening 30 minutes of this film is designed to thoroughly establish this fact — so the viewer can fully appreciate the events that follow it.

It turns out that the grenade is a dud.
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Posted in: Basic Science, Cancer, Clinical Trials, Medical Ethics, Politics and Regulation, Science and the Media

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Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2

NB: If you haven’t yet read Part 1 of this blog, please do so now; Part 2 will not summarize it.

At the end of Part 1, I wrote:

We do not need formal statistics or a new, randomized trial with a larger sample size to justify dismissing the Gonzalez regimen.

In his editorial for the JCO, Mark Levine made a different argument:

Can it be concluded that [the] study proves that enzyme therapy is markedly inferior? On the basis of the study design, my answer is no. It is not possible to make a silk purse out of a sow’s ear.

That conclusion may be correct in the EBM sense, but it misses the crucial point of why the trial was (ostensibly) done: to determine, once and for all, whether there was anything to the near-miraculous claims that proponents had made for a highly implausible “detoxification” regimen for cancer of the pancreas. Gonzalez himself had admitted at the trial’s inception that nothing short of an outcome matching the hype would do:

DR. GONZALEZ: It’s set up as a survival study. We’re looking at survival.

SPEAKER: Do you have an idea of what you’re looking for?

DR. GONZALEZ: Well, Jeff [Jeffrey White, the director of the Office of Cancer Complementary and Alternative Medicine at the NCI—KA] and I were just talking a couple weeks ago. You know, to get any kind of data that would be beyond criticism is—-always be criticism, but at least three times.

You would want in the successful group to be three times — the median to be three times out from the lesser successful groups.

So, for example, if the average survival with chemo, which we suspect will be 5 months, you would want my therapy to be at least — the median survival to be at least 15, 16, 17 months, as it was in the pilot study.

We’re looking for a median survival three times out from the chemo group to be significant.

Recall that the median survival in the Gonzalez arm eventually turned out to be 4.3 months.

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Posted in: Cancer, Clinical Trials, Health Fraud, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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My NCCAM Wish List

For a number of reasons, well-argued many times here on SBM, it would be beneficial to American citizens if the National Center for Complementary and Alternative Medicine (NCCAM) were abolished. This does not seem to be in the cards anytime soon. Here, then, are my suggestions for making the Center less dangerous and less of a marketing tool for pseudomedicine than it has been since its inception. Some suggestions might even make the Center somewhat useful. They are listed in order of priority. The Center should:

1. Abandon all unethical trials, beginning with the Trial to Assess Chelation Therapy (TACT, which is under the joint auspices of the NHLBI). This should be done in a very public manner. The reasons for abandoning the TACT, in summary, are as follows.

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Posted in: Medical Ethics, Politics and Regulation, Science and Medicine

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“Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part II: Loose Ends)

Last week I discussed the dismal results of the “Gonzalez Trial” for cancer of the pancreas,* as reported in an article recently posted on the website of the Journal of Clinical Oncology. I promised that this week I’d discuss “troubling information, both stated and unstated [in the report],” and also some ethical issues. More has come to light in the past few days, including Nicholas Gonzalez’s own voluminous, angry response to the JCO article. I’ll comment upon that below, but first a brief review.

The trial was begun in 1999 under the auspices of Columbia University, after Rep. Dan Burton had pressured NCI Director Richard Klausner to fund it. It was originally conceived as a randomized, controlled trial comparing the “Gonzalez Regimen” to standard chemotherapy for cancer of the pancreas. In the first year, however, only 2 subjects had been accrued, purportedly because those seeking Gonzalez’s treatment were not willing to risk random assignment to the chemotherapy arm. In 2000, the protocol was changed to a “prospective, cohort study” to allow potential subjects to choose which treatment they would follow. Gonzalez himself was to provide the ‘enzyme’ treatments.

After that there was little public information about the trial for several years, other than a few determination letters from the Office of Human Research Protections and a frightening account of the experience of one subject treated by Gonzalez. By 2006 or so, those of us who pay attention to creeping pseudomedicine in the academy were wondering what had become of it. About a year ago we found out: the trial had been quietly “terminated” in 2005 after it met “pre-determined stopping criteria.” As explained here, that meant that the Gonzalez group had not fared well.

Four years after the trial’s ‘termination,’ the report was finally published: The Gonzalez cohort had not only fared much worse than the cohort that received chemotherapy, but it had fared worse than a comparable group of historical controls. Here, again, is the survival graph from the JCO paper:

Snapshot 2009-09-11 16-16-15

The Gonzalez group had also fared much worse in ‘quality of life’ scores, which included a measure of pain.

Now let’s read between the lines. Forgive me for taking shortcuts; I’m a little pressed for time. (more…)

Posted in: Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Science and Medicine, Science and the Media

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“Gonzalez Regimen” for Cancer of the Pancreas: Even Worse than We Thought (Part I: Results)

ResearchBlogging.org

Review

One of the more bizarre and unpleasant “CAM” claims, but one taken very seriously at the NIH, at Columbia University, and on Capitol Hill, is the cancer “detoxification” regimen advocated by Dr. Nicholas Gonzalez:

Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

Veteran SBM readers will recall that in the spring of 2008 I posted a series of essays* about this regimen and about the trial that compared it to standard treatment for subjects with cancer of the pancreas. The NIH had funded the trial, to be conducted under the auspices of Columbia, after arm-twisting by Rep. Dan Burton [R-IN], a powerful champion of quackery, and much to the delight of the “Harkinites.”

In the fall of 2008 I posted an addendum based on a little-known determination letter that the Office for Human Research Protections (OHRP) had sent to Columbia during the previous June. The letter revealed that the trial had been terminated in October, 2005, due to “pre-determined stopping criteria.” This demonstrated that Gonzalez’s regimen must have been found to be substantially worse than the current standard of care for cancer of the pancreas, as ineffective as that standard may be. I urge readers who require a review or an introduction to the topic to read that posting, which also considered why no formal report of the trial had yet been made available.

Now, finally, the formal report has been published online by the Journal of Clinical Oncology (JCO):

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Posted in: Cancer, Clinical Trials, Health Fraud, Herbs & Supplements, Medical Academia, Medical Ethics, Politics and Regulation, Science and Medicine

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The “Gonzalez Trial” for Pancreatic Cancer: Outcome Revealed

A Review

Dr. Lipson’s “detoxification” post on Thanksgiving Day and Dr. Gorski’s recent post about “Gerson Therapy” were timely, because last weekend I noticed something that I should have noticed months ago. Before delivering the punch line, let me remind you, Dear Reader, of the nature of the topic. The regimen advocated by Nicholas Gonzalez is a variation of a “detoxification” treatment for cancer that has been around, in one form or another, for more than 50 years (“Gerson Therapy” is another example).† Here is the National Cancer Institute’s (NCI) description:

Patients receive pancreatic enzymes orally every 4 hours and at meals daily on days 1-16, followed by 5 days of rest. Patients receive magnesium citrate and Papaya Plus with the pancreatic enzymes. Additionally, patients receive nutritional supplementation with vitamins, minerals, trace elements, and animal glandular products 4 times per day on days 1-16, followed by 5 days of rest. Courses repeat every 21 days until death despite relapse. Patients consume a moderate vegetarian metabolizer diet during the course of therapy, which excludes red meat, poultry, and white sugar. Coffee enemas are performed twice a day, along with skin brushing daily, skin cleansing once a week with castor oil during the first 6 months of therapy, and a salt and soda bath each week. Patients also undergo a complete liver flush and a clean sweep and purge on a rotating basis each month during the 5 days of rest.

As unlikely as it may seem, in 1999 American taxpayers began paying for people with cancer of the pancreas to be subjected to that regimen, in a trial sponsored by the National Center for Complementary and Alternative Medicine (NCCAM) and the NCI, conducted under the auspices of Columbia University. Gonzalez provided the treatments. A few months ago I presented a multi-part treatise on the “Gonzalez regimen” and the trial. It demonstrated that all evidence, from basic science to clinical, including the case series that supposedly provided the justification for the trial, had failed to support any real promise (the case series had previously been considered by reader Dr. Peter Moran, who also found them wanting).

It showed that the impetus for the trial, as has been true for other regrettable trials of implausible health claims, can be traced not to science but to the reactionary politics of anti-intellectual populism: initially to Laetrile and to the “Harkinites,” and more recently to the Honorable Dan Burton (R-IN). It reported that there were major problems with the Gonzalez trial from the outset, and that for at least one subject the regimen was more torture than therapy. It reported that for unclear reasons the trial had come to a halt a couple of years ago, and that it appeared that there would never be a report of its findings.

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Posted in: Cancer, Clinical Trials, Medical Academia, Medical Ethics, Politics and Regulation

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“Patient-Centered Care” and the Society for Integrative Oncology

Should Medical Journals Inform Readers if a Book Reviewer can’t be Objective?

At the end of last week’s post I suggested that book reviewer Donald Abrams and the New England Journal of Medicine had withheld information useful for evaluating Abrams’ review: that he is the Secretary/Treasurer of the Society for Integrative Oncology (SIO), the organization of which Lorenzo Cohen, the first editor of the book that Abrams reviewed,* is President. I also promised to look at material from the book and from the Society’s website in order to discover “data that will allow even the most conventional oncologists to appreciate [the value of 'integrative' methods].”

There is little question that Abrams and Cohen know each other, or at least that Abrams couldn’t have been expected to write an entirely objective review of Cohen’s book. Abrams is the Program Chair for the Society’s upcoming 5th International Conference, sponsored by the American Cancer Society. He and Cohen will be sharing the stage for the “Intro/Welcome.” Does it matter that most NEJM readers wouldn’t have learned of this association by reading the review? Probably not, in the case of readers who are well-versed in the misleading language of “CAM.”

I believe that most readers of medical journals are not so sophisticated. Otherwise, how could it have been so easy for “CAM” literature to seep through the usual evaluative filters, not only in medical schools and government but in the editorial boardrooms of prestigious journals? For anyone from the Journal who might be following this thread, Dr. Sampson’s satirical but deadly serious account of “how we did it” is obligatory reading.

Do “Integrative Oncology” Methods have Value?

Now let’s take a look at what Dr. Cohen’s book and the SIO are up to. The book’s introduction and table of contents are available on Amazon.com. The introduction contains the usual, misleading assertions and falsehoods that are ubiquitous in “CAM” promotions. I’ve added a few hyperlinks:

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Posted in: Book & movie reviews, Cancer, Energy Medicine, Medical Ethics

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